Striking the balance between ethical integrity and clinical effectiveness

Dr Shivani Sharma, Lab Director & Vice President, CORE Diagnostics stresses that while advanced diagnostics are lifesaving, it is essential to ensure that these innovations do not compromise patient rights or violate fundamental medical ethics

Striking a balance between ethical integrity and clinical effectiveness is a crucial challenge in India’s healthcare system. Recent advances in diagnostic technologies have transformed how diseases are detected and treated, bringing significant improvements in patient outcomes. However, these developments also raise pressing ethical concerns related to access, affordability, and transparency. While advanced diagnostics are lifesaving, it is essential to ensure that these innovations do not compromise patient rights or violate fundamental medical ethics.

The expanding role of diagnostics in India

Over the past decade, the Indian healthcare sector has experienced exponential growth, particularly in diagnostic services. The pandemic highlighted the critical role of accurate diagnostics in managing public health, propelling India’s diagnostic industry to a market size of Rs 1.36 trillion by 2026, growing at an impressive CAGR of 14 per cent. This growth reflects the increasing reliance on diagnostic solutions for early detection, disease management, and treatment personalisation, especially for conditions such as cancer, cardiovascular diseases, and genetic disorders. In fields like cancer diagnostics, early and precise detection is paramount for improving patient outcomes. Advanced diagnostic tools—like molecular diagnostics and genetic testing—are now becoming more accessible, allowing physicians to make better-informed decisions. However, with the increasing complexity of testing options comes a heightened need for clinical accountability and ethical oversight.

Ethical challenges in diagnostics

While diagnostic technologies have advanced, accessibility remains uneven. India’s rural areas, where over 65 per cent of the population resides, often have limited access to specialised diagnostic centers. This geographic disparity creates a healthcare divide, where advanced diagnostic solutions are available primarily to urban, affluent populations. The National Health Mission has emphasised the importance of equity, yet there is much ground to cover in ensuring rural healthcare facilities have access to the latest diagnostic tools.

Another ethical challenge relates to patient autonomy and informed consent. As diagnostic technologies become more sophisticated, particularly in the fields of genomics and personalized medicine, there’s a growing need for transparency in how test results are used and shared. Patients should be made fully aware of the implications of their diagnostic results, including potential data-sharing issues and the emotional burden of knowing hereditary risks.

Data analysis and digital pathology also introduce new ethical complexities. The use of machine learning and AI in diagnostics must be accompanied by transparency in data sources and algorithmic interpretation to prevent biases and misdiagnosis. Furthermore, the rapid adoption of point-of-care (POC) diagnostics, such as portable devices for quick health assessments, has increased access but requires stringent quality checks and clinical validation to maintain ethical and clinical integrity. Recent updates from the Indian Council of Medical Research (ICMR) provide important guidelines on ethical standards in medical practice, particularly concerning digital healthcare and artificial intelligence (AI). These guidelines address critical issues such as informed consent, data protection, algorithmic transparency, and equity. They aim to establish a framework for responsible AI deployment while safeguarding against bias and discrimination, particularly within vulnerable populations.

Additionally, the Indian Journal of Medical Ethics points out the issue of overdiagnosis, especially in cases involving expensive diagnostic tests. While tests like PET scans and genomic sequencing offer detailed insights, there is growing concern about their overuse, leading to unnecessary treatments and patient anxiety. Clinicians must strike a balance between providing diagnostic accuracy and preventing the over-diagnosis of conditions that may not require immediate intervention.

Bridging the ethical-clinical divide

Healthcare professionals, regulatory bodies, and diagnostic centers are working towards solutions that balance clinical effectiveness with ethical standards. In the context of genetic diagnostics, ethical frameworks have become crucial to maintaining patient trust and safeguarding sensitive information. Initiatives like the National Guidelines for Biomedical and Health Research involving Human Participants (2017) emphasise the importance of ethical compliance, particularly in genomic research. These guidelines ensure that diagnostic centers adhere to high standards of patient data protection and informed consent, a necessary measure to prevent the misuse of genetic information. To address the accessibility gap in diagnostics, government programs like the Ayushman Bharat-Pradhan Mantri Jan Arogya Yojana (PMJAY) are working to provide free healthcare services, including diagnostics, to nearly 50 crores Indians, with a focus on underserved populations.

Efforts are also underway to establish diagnostic centers in tier 2 and tier 3 cities to ensure equitable access. In parallel, many diagnostic labs, particularly those offering advanced tests like molecular diagnostics, are adopting international accreditation standards, such as those from the National Accreditation Board for Testing and Calibration Laboratories (NABL), which enforce rigorous quality control measures. Currently, there are over 2,500 NABL-accredited testing laboratories in India, strengthening both clinical accuracy and ethical integrity. Furthermore, the clinical workforce must receive ongoing education and training on ethical issues in molecular diagnostics and genomics to help clinicians explain complex test results to patients, minimising the risks of overdiagnosis or misinterpretation.

The role of a digital oath in upholding ethical standards

As digital health technologies transform the medical landscape, a “Digital Oath”—similar to the traditional Hippocratic Oath—could help guide the ethical use of digital tools in clinical settings. Such an oath would ensure that patient data is handled with integrity, transparency, and confidentiality. It would emphasise responsible data sharing, respect for patient privacy, and maintaining ethical standards when using technologies like AI and telehealth.

Conclusion

As advanced testing becomes increasingly central to healthcare, it is important that diagnostic providers, policymakers, and healthcare professionals work together to uphold patient rights, ensure transparency, and expand access to advanced diagnostics. Ethical practices must evolve hand-in-hand with technological progress to create a healthcare ecosystem that is both innovative and equitable.